Teva Recalls Prednisolone Oral Solution for Failed Stability Specifications
Teva Pharmaceuticals USA is recalling specific lots of Prednisolone Oral Solution because they failed stability specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The source text cites failed stability specifications without reporting any illnesses or injuries.
Plain-English summary
Teva Pharmaceuticals USA is recalling 49,089 bottles of Prednisolone Oral Solution USP, 15 mg/5mL, 240 mL bottles. The affected product is an alcohol-containing prescription liquid manufactured in Canada by Contract Pharmaceuticals Limited Canada for Teva Pharmaceuticals USA.
The recall was initiated because the product failed stability specifications. The affected lots are # 94358 (Exp. 05/17), # 94920A (Exp. 07/17), and # 97083A (Exp. 12/17). The product was distributed nationwide.
Consumers should check their medication for the NDC 0093-6118-87 and the lot numbers listed above. If the product matches these details, they should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 49,089
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # 94358
- Exp. 05/17 Lot # 94920A
- Exp. 07/17 Lot # 97083A
- Exp. 12/17
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · stability failure
See all →- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
- ModerateSafecor Health Recalls Fluphenazine HCl Elixir Due to Stability Failures
FDA (Drugs) · 2026-09-23
Similar recalls
- HighPrednisolone Oral Solution Recalled Due to Manufacturing Standards Deviation
FDA (Drugs) · 2023-06-07
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Low Potency
FDA (Drugs) · 2017-02-01
- SevereMethylprednisolone Acetate Injectable Suspension Recall: Sterility Assurance
FDA (Drugs) · 2021-08-25
- HighTeva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide
FDA (Drugs) · 2019-04-24
- SevereTeva Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns
FDA (Drugs) · 2021-05-26
- SevereMethylprednisolone Acetate Injectable Suspension recalled for sterility concerns
FDA (Drugs) · 2021-08-25